Company ยท US
Renovis Surgical Technologies, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2019. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 |
| HWC | Screw, Fixation, Bone | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2019 | K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System Renovis Surgical Technologies | JWH |
| Dec 7, 2018 | K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System Renovis Surgical Technologies | OVD |
| Sep 11, 2018 | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System Renovis Surgical Technologies | MAX |
| Jun 14, 2018 | K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System Renovis Surgical Technologies, Inc. | OVD |
| Nov 16, 2017 | K171543 | Renovis Surgical Hip Replacement System Renovis Surgical Technologies | OQG |
| Aug 8, 2017 | K170888 | Renovis S141 Lumbar Interbody Fusion System Renovis Surgical Technologies | MAX |
| Mar 16, 2016 | K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Renovis Surgical Technologies | OVE |
| Sep 25, 2015 | K152193 | Renovis Anterior Cervical Plate System Renovis Surgical Technologies, Inc. | KWQ |
| May 11, 2015 | K143647 | Renovis Surgical Hip Replacement System Renovis Surgical Technologies, Inc. | OQG |
| Feb 6, 2015 | K143126 | Renovis S141 Lumbar Interbody Cage System Renovis Surgical Technologies | MAX |
| Nov 4, 2014 | K141676 | RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM Renovis Surgical Technologies, Inc. | LPH |
| Oct 15, 2014 | K142095 | RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. | OVD |
| Sep 2, 2014 | K141370 | RENOVIS CEMENTED HIP SYSTEM Renovis Surgical Technologies, Inc. | JDI |
| Apr 11, 2014 | K132312 | RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM Renovis Surgical Technologies, LLC | LPH |
| Mar 27, 2014 | K140106 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. | OVD |
| Sep 19, 2013 | K131354 | RENOVIS BIPOLAR HIP SYSTEM Renovis Surgical Technologies, LLC | KWY |
| Sep 18, 2013 | K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, LLC | OVD |
| Feb 14, 2013 | K120038 | A200 KNEE SYSTEM Renovis Surgical Technologies, LLC | OIY |
| Jun 13, 2012 | K112897 | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS Renovis Surgical Technologies, LLC | OQG |
| May 15, 2012 | K111940 | S 100 PEDICLE SCREW SYSTEM Renovis Surgical Technologies, LLC | MNH |
| Dec 9, 2011 | K113084 | RENOVIS CANNULATED SCREW SYSTEM Renovis Surgical Technologies, LLC | HWC |
| May 11, 2011 | K110965 | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM Renovis Surgical Technologies, LLC | KTT |
| Dec 7, 2010 | K101682 | S 100 PEDICLE SCREW SYSTEM Renovis Surgical Technologies, LLC | MNI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||